Dimetane™ Allergy Relief -25mg

Dimetane™ Allergy Relief -25mg
SPL v1
SPL
SPL Set ID 484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f
Route
ORAL
Published
Effective Date 2026-01-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Gelatin, Unspecified Glycerin Polyethylene Glycol 400 Propylene Glycol Water Sorbitol Fd&c Blue No. 1 Gelatin Sorbitan

Identifiers & Packaging

Pill Appearance
Imprint: BZ3 Shape: oval Color: white Size: 15 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-27

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
 adults and children 12 years and over                      1 softgel
 children under 12 years                                         do not use 

Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • Store between 20-25°C (68-77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) 
  • Protect from moisture and light.
  • Tamper Evident: do not use if foil seal under cap is broken or missing.
Inactive Ingredients

25mg:- Gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution

50mg:- FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, purified water, sorbitol sorbitan solution

Questions Or Comments

Call 1-877-474-7464

This product is neither manufactured nor distributed by the owner of the registered trademark Benadryl ® and Liqui-Gels ®

DIMETANE TM is a trademark owned by Rising Pharma Holdings, Inc.

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. Lic. No.: 10/UA/2016

Principal Display Panel

NDC 57237-367-99

Dimetane TM  

Diphenhydramine HCl 25 mg

Allergy Relief 

Antihistamine

Compare to the active ingredient in Benadryl ®Allergy Liqui-Gels ®† 

For the Temporary Relief of 

Runny Nose Itchy, watery eyes, Sneezing, Itchy throat or nose

NDC 57237-368-99

Dimetane TM

Diphenhydramine HCl 50 mg

Allergy Relief Extra Strength

Antihistamine

Compare to the active ingredient in Benadryl ® Allergy Liqui-Gels ®* Extra Strength®†

For the Temporary Relief of

Runny Nose Itchy, watery eyes, Sneezing, Itchy throat or nose

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Active Ingredient (in Each Softgel)

Diphenhydramine HCl 25 mg & 50 mg

Ask A Doctor Before Use If You Have
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Structured Label Content

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antihistamine

Directions
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
 adults and children 12 years and over                      1 softgel
 children under 12 years                                         do not use 

Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • Store between 20-25°C (68-77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) 
  • Protect from moisture and light.
  • Tamper Evident: do not use if foil seal under cap is broken or missing.
Inactive Ingredients

25mg:- Gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution

50mg:- FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, purified water, sorbitol sorbitan solution

Questions Or Comments (Questions or comments)

Call 1-877-474-7464

This product is neither manufactured nor distributed by the owner of the registered trademark Benadryl ® and Liqui-Gels ®

DIMETANE TM is a trademark owned by Rising Pharma Holdings, Inc.

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. Lic. No.: 10/UA/2016

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 57237-367-99

Dimetane TM  

Diphenhydramine HCl 25 mg

Allergy Relief 

Antihistamine

Compare to the active ingredient in Benadryl ®Allergy Liqui-Gels ®† 

For the Temporary Relief of 

Runny Nose Itchy, watery eyes, Sneezing, Itchy throat or nose

NDC 57237-368-99

Dimetane TM

Diphenhydramine HCl 50 mg

Allergy Relief Extra Strength

Antihistamine

Compare to the active ingredient in Benadryl ® Allergy Liqui-Gels ®* Extra Strength®†

For the Temporary Relief of

Runny Nose Itchy, watery eyes, Sneezing, Itchy throat or nose

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Active Ingredient (in Each Softgel) (Active Ingredient (in each softgel))

Diphenhydramine HCl 25 mg & 50 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)